The new monovalent booster – approved by the FDA/CDC - Yesterday’s Florida Health roundtable of experts convened by Governor de Santis and Surgeon General Ladapo – on twitter, 45 minutes

From here:

(19) Ron DeSantis on X: "Governor DeSantis Hosts Discussion on COVID-19 Boosters https://t.co/0NtSSZbdBo" / X (twitter.com)

“Governor DeSantis Hosts Discussion on COVID-19 Boosters”

I took the twitter link embedded in the excellent C&C, Jeff Childers daily email here:

(100) ☕️ A LOT OF TWINKIES ☙ Thursday, September 14, 2023 ☙ C&C NEWS 🦠 (coffeeandcovid.com)

Mr Childers summarizes the main points as:

All the panel experts agreed that the FDA rushed booster approval through without having a scrap of evidence of safety or efficacy.

At 24:30 in the clip, standout Stanford professor Jay Bhattacharya opined that the old FDA would never have approved the shots:

A small trial, with a biomarker? Where you’re recommending it at scale to the entire population? No. I mean, I think that it is an absolutely irresponsible move by the FDA to approve this product, and of the CDC to recommend that everyone take it.

The European agencies are doing something very, very different with this. They’re being much more careful given the paucity of data. Much more responsible.

We need more data… How is a doctor supposed to advise a patient…? There’s no answer they can give that’s backed by actual data.

The FDA in historical times would — no chance would they have approved this, Governor, no way.

And I don’t understand what’s going on at the FDA right now that they would, and the CDC would, recommend it at scale.

At 20:00, Traci Beth Hoeg, MD, PhD, told Governor DeSantis the pre-clinical data supplied by the manufacturers to the FDA showed an unacceptably-high level of serious adverse events:

[Serious adverse events occurred in the preclinical trials in] one out of 50, so it was two percent. So, no, that’s very concerning. It was a medically-attended adverse event. I’ve had a number of people look, as well as myself, and we cannot figure out what that adverse event was. It doesn’t appear that it was reported.

But obviously, if you need a medical professional to attend to that event, and the study authors deemed that it was related to the vaccine, they  had other adverse events in the trial as well that they found were unrelated to the vaccine.

The fact they found this was actually related to the vaccine, that’s very concerning. When we look at the harms side of the ledger, we know there was this — it’s two percent out of this 50 people who got it — that’s a high rate of adverse events.

At 16:45, Patrick Whelan, MD, PhD, calculated the risk of a serious adverse event from the jabs was at least one in 800 people who took the shot:

We found that there were significant adverse events in about one in 800 people who were vaccinated, which is a pretty high level of serious adverse events. It would have been even higher if it weren’t for the fact that the Moderna placebo group had a very high adverse events rate.

The new boosters have not been tested for safety and effectiveness at all, and certainly not in children at this point.

I take care of many children who have a neurobehavioral condition called Panda’s syndrome, and I take care of a lot of teenagers who have long-covid kind of symptoms. There are real concerns about the role the coronavirus and the vaccines have played in triggering these under-studied disorders.

It seems to me that, in the best of all worlds, we would be demanding now that the vaccine makers release patient-level data to researchers in order to balance the real risks against the probable benefits in selected populations.

In England, Mexico, and countries across Europe, they’re only asking people over 65, and people who are immuno-deficient, to be vaccinated with the new boosters.

Dr. Whelan also noted that the federal government isn’t even really trying to figure out the risks of the shots:

There is no robust follow-up now with regards to the side-effects of the older vaccines. I would think we’d want to create a means by which the parents of every covid-vaccinated child would be called at a one-week, one-month, six-month interval to ask how they’re doing, rather than making people navigate the vicissitudes of the VAERS system.

I had a patient, a 7-year-old, who died in our hospital after he received a covid vaccine, and VAERS would not allow me to update my initial VAERS report to indicate the child had actually died subsequently.

Even with the VAERS database, we’re under-appreciating how grave the risks of the vaccine might be.

Following the discussion, Florida’s outstanding Harvard-trained Surgeon General Joseph Ladapo announced the state health department will soon issue guidance to Florida doctors that: (1) the shots are not recommended for anyone under 65 who is not in a high-risk group, and (2) doctors must discuss the absence of safety and efficacy data with all patients when discussing the boosters, as part of informed consent.”

Onwards!

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